Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Trial of Reminder Focused Positive Psychiatry in Comorbid Attention Deficit Hyperactive Disorder With Posttraumatic Stress Disorder
This feasibility study investigates the impact of reminder-focused-positive-psychiatry (RFPP)
on attention-deficit-hyperactive-disorder (ADHD) and posttraumatic-stress-disorder (PTSD)
symptoms, vascular-function, inflammation and well-being of adolescents with comorbid ADHD &
PTSD.
In this randomized clinical trial, 24 subjects with comorbid ADHD and PTSD, aged 12-18 years
old, free of known medical and other major psychiatric disorders, will be recruited from the
pool of eligible subjects at Los Angeles and Kern County Children Mental Health Centers
(>1500 subjects) after obtaining informed consent from parents as well as subjects'
assentment. Commonwealth and Oswell Kern County Mental Health Clinic will be used for
subjects enrollment, randomization as well as study implementation from trauma disorder
clinic. Kern Medical will be used for manuscript write up and analyses.
Adolescents will be randomized to: group-RFPP or trauma-focused
group-cognitive-behavioral-therapy (TF-CBT). Participants will complete
twice-weekly-intervention for 6-weeks-trial. The group-RFPP-intervention will be inclusive of
RFPP interventions on a) traumatic-reminders, and b Avoidance & negative-cognition.
Vascular-function-measured as temperature-rebound (TR), C-reactive-protein (CRP),
homocysteine, SNAP-questionnaire, Clinician-Administered PTSD-Scale-children-version
(CAPS-CA) and neuropsychiatric-measures will be measured at baseline and 6th week. Subjects
will be followed for 12 months.
Parents and subjects will be informed of the risks associated with use of venipuncture and
loss of confidentiality of collected information.
PTSD and ADHD are major public health problems. Many individuals with comorbid ADHD and PTSD
continue to suffer despite treatment with FDA approved medications including antidepressants
(sertraline and paroxetine), prazosin and/or the Institute of Medicine approved
psychotherapy. Long-term outcomes with even the most intensive treatments, although
significant, were modest, and reveal persistent morbidity and disability for many individuals
with PTSD, especially in those with comorbid ADHD.19 While current treatments focused on
treatment to reduce the associated suffering and disability of morbid ADHD and PTSD. These
interventions are, however, not sufficient to promote human welfare, improve levels of
positive psychosocial characteristics (PPCs), and resilience. Positive psychiatry (PP)
focuses on promoting well-being, enhancing behavioral and mental wellness in both youth and
adults20, however its impact on youth with comorbid PTSD and ADHD has not been studied. We
hypothesize that PP intervention would significantly enhance vascular function, resilience,
wellbeing, increase posttraumatic growth and reduce inflammation in morbid ADHD and PTSD.
This randomized trial will the first to investigate the impact of psychiatric positive
interventions, as opposed to intervention on ameliorating vulnerability, on adolescents with
morbid ADHD and PTSD. Findings of this study can provide a better understanding of impact of
PP on psychiatric and biomolecular characteristics of adolescent with PTSD and ADHD. If
successful, this proposal will be available for large scale studies following which it could
potentially be deployed in daily clinical practice.
RESEARCH METHOD:
In this randomized clinical trial, the three related and overlapping specific aims are
directed to examine the feasibility of PP intervention, as well as its impact on positive
psychological wellbeing, and neurovascular inflammation in adolescent subjects with comorbid
ADHD and PTSD.
Synopsis. In this randomized clinical trial, 24 subjects with comorbid ADHD and PTSD, aged
12-18 years old, free of known medical and other major psychiatric disorders, will be
recruited from the pool of eligible subjects at Los Angeles and Kern County Children Mental
Health Centers (>1500 subjects) after obtaining informed consent from parents as well as
subjects' assentment. Commonwealth and Oswell Kern County Mental Health Clinic will be used
for subjects enrollment, randomization as well as study implementation from trauma disorder
clinic. Kern Medical will be used for manuscript write up and analyses.
Parents and subjects will be informed of the risks associated with use of venipuncture and
loss of confidentiality of collected information. Eligible subjects will be randomized to 1)
PP group intervention, or 2) control condition group (12 in each group) for 6 week
intervention and 6 week of follow up.
Recruited subject will be followed before, during and after interventions. Both groups will
be on adequate stimulant therapy for ADHD. Group PP intervention consists of 12 sessions of
group PP in 6 week that will be completed by the participant with the guidance of a trainer.
Sham control condition consists of 12 sessions in 6 week of group exercises that will be
completed by the participant with the guidance of a trainer.
All subjects will undergo radial artery flow mediated dilatation, a measure of vascular
function, venipuncture for measuring of CRP, homocysteine and IL-6, as well as completion of
positive psychiatry and wellbeing batteries at baseline, 3rd and 6th of intervention and 12th
week follow up.
A- Measurements A1.History and Physical Exam (H&P): All consented patients will undergo a
baseline H&P, intervention, and post-trial observation periods by a physician.
A2. Medications: All medications during pre-trial, intervention and post-trial will be
charted A3. Psychiatry Batteries: SNAP teacher and parent questionnaire, Positive
Psychotherapy Inventory, VIA Survey of Character Strengths, PERMA, PANAS, optimism,
posttraumatic growth inventory, Connor Davidson resilience scale, Clinician Administered PTSD
Scale (CAPS) children version will be measured at baseline, 3rd, 6th and 12th week.
A4. Vascular Function Assessment via FMD: After resting in a supine position in a room with
temperature 23° to 25° C for 30 minutes, brachial artery endothelial function will be
assessed noninvasively by ultrasound using reactive hyperemia procedure. Brachial artery
diameter above antecubital crease will be measured at least 60 cycles from baseline to 5 min
cuff inflation, and 5 min post cuff deflation.
A5.Venipuncture and laboratory measurements: Venous blood samples of all subjects after 8
hours of fasting will be drawn at baseline, 3rd, 6th and 12th week. The assessment of
C-reactive protein (CRP) and homocysteine will be performed using the standard techniques.
The concentrations of IL-6 will be determined using commercially available solid-phase
sandwich enzyme-linked immunosorbent assay kits. The range of detection is 15-1540 pg/ml for
IL-6.21
B- Interventions:
B1.Reminder Focused Positive Psychiatry: RFPP group will receive 6 week (12 sessions and 12
exercises) of positive psychiatry to improve wellbeing. The group PP exercises are inclusive
of Posttraumatic Growth, Resilience, Gratitude and Optimism, Self-regulation and Personal
Strength, Enjoyable and meaningful activities, Personal mastery and self-efficiency. Groups
last approximately 60 minutes, and positive responding (responding to others in an active and
constructive way), personal strengths, gratitude, forgiveness and identifying positives from
negative situations will be included. Nondirective prompts will be used to stimulate in-depth
discussion. Feedback from subjects will be captured. All facilitators have experience of
facilitating therapeutic groups and of working with individuals with a diagnosis of ADHD and
PTSD. Facilitators participate in all exercises themselves, they share personal examples from
their own lives with the group, and are encouraged to do the 'ongoing exercise' in their own
time. Participants are not prohibited from sharing distressing, unpleasant, or negative
states and experiences in the group. Negative contributions are validated but not focused on.
Instead, facilitators establish a link between the negative experience and one or more of the
intervention's target areas.
C. Statistical Analysis:
All statistical analyses will be performed during the last 4 months of the study. T test and
Chi Square test will be used to assess differences between groups. The association between PP
and control condition will be analyzed by linear and mixed regression analyses. In addition,
the change in overall symptoms, ADHD and PTSD specific symptoms, and neurovascular
inflammation in response to PP will be evaluated. These analyses will be adjusted for
demographics, mental and medical covariates.
D. Sample Size for Specific Aim 1-3:
A measurable change in vascular function and increase in PERMA are outcomes of interest. The
sample size of 12 per group that has been chosen based on priori study, will detect a 20%
difference in vascular function and PERMA score amongst groups, with a study power of 0.8 and
significance level of 0.05.
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